Howard K Himes Director Karen L. Smith, M.D., M.P.H. Public Health Officer 2344 Old Sonoma Road Building G Napa, California 94559
HHSA EMERGENCY OPERATIONS PUBLIC HEALTH PLAN (EOP) – APPENDIX 3 DIVISION and STATE PLAN REVISED May 2014
NAPA COUNTY HEALTH AND HUMAN SERVICES AGENCY (HHSA) ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014
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NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page ii ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 ACKNOWLEDGEMENTS AND SOURCES
Procedures included in this plan are intended as guidelines for response. Actual actions will vary depending on the requirements of the emergency and available resources.
This plan is based on guidelines from the California Department of Public Health. The plan was originally published in 2005 and updated in January 2009, August 2010, January 2011, May 2012 and May 2014.
PLAN APPROVAL
This plan has been reviewed and approved by the Napa County Health and Human Services Agency Director and the Public Health Officer and is the official Bioterrorism Countermeasure Distribution Plan for Napa County. The plan is effective as of January 31, 2010.
RECORD OF CHANGES, UPDATES AND REVISIONS
Plan Section Description of Change Date Signature and Page #.
Sections 2, Updated to reflect the State of California’s May 2012 3.4, 3.5, and Medical/Health Emergency Operations Appdx A Manual and related guidance for the MHOAC program.
Cover Page Updated HHSA Director’s name May 2014
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NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page iv ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 CONTENTS
1. INTRODUCTION ...... 1 1.1 Purpose ...... 1 1.2 Scope of the Plan ...... 2 1.3 Assumptions ...... 2
2. CONCEPT OF OPERATIONS ...... 4
3. OPERATIONAL AREA RSS ORGANIZATION ...... 6 3.1 Op Area RSS Organization Roles and Responsibilities ...... 7
4. REQUESTING THE STRATEGIC NATIONAL AND STATESTOCKPILE ...... 8 4.1 Detection ...... 8 4.2 Investigation ...... 9 4.3 Consultation ...... 9 4.4 Requesting the SNS ...... 10 4.5 Accessing Local, Regional and State Resources ...... 10 4.6 Receiving, Storing And Staging (RSS) The Stockpile ...... 13 4.7 State transfer of resources ...... 13
4.7.1 Designated Operational Area Officials ...... 13
4.7.2 Transfer Documents ...... 13 4.8 RSS Warehouse ...... 14 4.9 RSS Warehouse Functions ...... 14
4.9.1 Receive ...... 14
4.9.2 Managing Controlled Substances ...... 15
4.9.3 Repackaging Of Bulk Medications ...... 15 4.10 Sort and Store ...... 15
4.10.1 Materiel Storage and Handling ...... 16
4.10.2 Environmental...... 16 4.11 Staging and Quality Control ...... 16 4.12 Dispatch/Delivery ...... 16 4.13 OA RSS Staffing ...... 17
4.13.1 Staffing OA RSS ...... 17 4.14 OA RSS Distribution and Transportation of Resources ...... 18
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page v ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 4.15 OA RSS Credentials/Badging for Entry to the RSS Site ...... 19 4.16 Security for the OA RSS Site, Transportation, and Points of Distribution ...... 19 4.17 OA RSS Communications ...... 21
5. OA RSS INVENTORY CONTROL AND TRACKING ...... 22 5.1 Non-medical Supplies ...... 23
6. OPERATIONAL AREA OFFICIALS AUTHORIZED TO SIGN FOR THE SNS ...... 23
7. RSS WAREHOUSE SET UP EQUIPMENT & SUPPLIES LIST ...... 24
8. POSITION CHECKLISTS FOR RSS PERSONNEL ...... 27 8.1 Op Area RSS BRANCH DIRECTOR ...... 27 8.2 Op Area RSS MATERIEL UNIT LEADER ...... 28 8.3 RSS INVENTORY CONTROL PERSONNEL ...... 29 8.4 RSS RECEIVING PERSONNEL ...... 30 8.5 RSS SORTING AND STORING PERSONNEL ...... 31 8.6 RSS STAGING/QUALITY CONTROL PERSONNEL ...... 32 8.7 Op Area RSS TRANSPORTATION UNIT LEADER ...... 33 8.8 Op Area RSS COMMUNICATIONS UNIT LEADER ...... 34 8.9 Op Area RSS COMMUNICATIONS/ IS COORDINATOR ...... 35 8.10 Op Area RSS SECURITY UNIT LEADER ...... 36 8.11 SECURITY for OA RSS FACILITY ...... 37 8.12 Op Area RSS SAFETY OFFICER ...... 38
9. PUBLIC HEALTH EMERGENCY ASSESSMENT CRITICAL DATA WORKSHEETS ...... 39
10. SNS INVENTORY FORMS ...... 41 10.1 SNS State to Local Transfer Form ...... 41 10.2 RSS SNS Inventory FORMS ...... 43
10.2.1 SNS RSS Tracking Forms’ Flow Charts ...... 43
10.2.2 SNS Receiving Verification Form ...... 44
10.2.3 Distribution Pick List Form ...... 44
11. MORE ABOUT THE STRATEGIC NATIONAL STOCKPILE ...... 45
12. INVESTIGATIONAL NEW DRUG/EMERGENCY USE AUTHORIZATION ...... 48 12.1 Emergency Use Authorization (EUA) ...... 48
12.1.1 Background ...... 48
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page vi ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 12.1.2 Local Public Health EUA Implementation ...... 49
12.1.3 Investigational New Drug (IND) Procedures ...... 50
13. REFERENCE MATERIALS - PROJECT BIOSHIELD ACT OF 2004, SEC. 564 ...... 56
14. REFERENCES ...... 61
15. GLOSSARY ...... 62
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1. INTRODUCTION
In 1999, Congress established the National Pharmaceutical Stockpile (NPS) Program and assigned it the mission of providing large quantities of essential medical items to states and communities during a large-scale emergency, whether natural or man-made. In March 2003, the name was changed to the Strategic National and State Stockpile (SNS) Program.
The Strategic National and State Stockpile Program is managed through the federal Centers for Disease Control and Prevention (CDC). It is comprised of large quantities of pharmaceuticals, medical materiel and equipment, and is kept in locations across the United States to ensure rapid delivery. The California Department of Public Health (CDPH) provides distribution of SNS assets from a predetermined State Receiving, Storage, and Staging (RSS) Warehouse location to any delivery point in California. In addition, the state maintains and manages its own pharmaceutical cache.
SNS resources are deployed to augment depleted state and local resources as needed to respond to large-scale public health emergencies.
CDC’s Technical Advisory Response Unit (TARU) is another level in the SNS Program. The team is comprised of logisticians, SNS operations experts, and U.S. Marshal(s). The team’s primary mission is to facilitate the transfer of SNS materiel to the State RSS Warehouse. They may advise state authorities on receiving, storing, staging, apportioning, distributing, replenishing, dispensing, and recovering the SNS materiel as well as storage and transportation issues.
Over time, the SNS Program has been extensively reviewed, exercise-tested and developed to include responding to specific public health emergencies such as Anthrax or Pandemic Flu, as well as undefined bio-agent event. Coupled with the State of California Department Public Health’s pharmaceutical cache, a broad range of materiel and pharmaceuticals are available to respond to a variety of infectious disease threats. What materiel is shipped will depend on the causative agent, the degree of laboratory and clinical confirmation of agent, the need for response and prophylaxis, and other factors.
1.1 PURPOSE
The purpose of this plan is to describe the procedures for requesting, receiving, managing, distributing and dispensing the contents of the Strategic National and State Stockpile .
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Once the decision is made to request the SNS, all portions of this plan will be activated and will proceed on the assumption that the request will be approved unless told otherwise.
1.2 SCOPE OF THE PLAN
The SNS Plan is presented as Appendix 3 of the Napa County Health and Human Services Agency (HHSA) Concept of Operations Plan (CONPLAN), Annex H of Napa County Emergency Operations Plan. This plan describes ONLY procedures for requesting, receiving, managing and distributing SNS pharmaceuticals and medical equipment/supplies to Points of Distribution (PODs) or dispensing sites.
Procedures for dispensing pharmaceuticals to the public are contained in the Countermeasure Distribution Plan, which is Annex H, Appendix 4 of the Napa County Emergency Operations Plan (EOP) The Countermeasure Distribution Plan describes procedures for activating, staffing, and managing mass prophylaxis from pre-designated Points of Distribution (PODs) in Napa County.
1.3 ASSUMPTIONS
A. When the decision is made to request the SNS, all portions of this plan are activated and proceed on the assumption that the request will be approved unless told otherwise.
B. State and local public health authorities and the medical community may know a biological threat is present when a large number of ill persons present with similar disease or a large number of deaths or unusual illness are noted in the population. However, they may not yet know what specific biological agent is causing the illnesses or deaths.
C. The first SNS shipment (the Push Package) will arrive within 12 hours of the federal decision to deploy the SNS and will reflect the request from the County. It may contain either a broad range (broad spectrum antibiotics) of materiel to protect and treat 100,000 + people from a non-specific illness or threat, or specific pharmaceuticals and supplies if the bio-agent is known.
D. Following identification of the specific biological agent causing illness, subsequent shipments from vendors (vendor-managed inventory) will contain quantities of specific drugs to combat the illness or threat.
E. The CDC will deploy SNS materiel to the State of California at only one predetermined location and will deliver individual, unit-of-use, prepackaged drugs.
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F. The State will deploy unit-of-use oral medications under the security and escort provided by the State (where possible) to the local jurisdiction almost immediately.
G. The Operational Area Emergency Operations Center (Op Area EOC) may be required to assist with transportation. The State will deploy SNS materiel to local jurisdictions according to their request(s).
H. The State may assume the role of repackaging all SNS bulk items, should the need arise.
I. This plan assumes the use of a local staging area which is called the Operational Area Receipt, Storage and Staging Area (Op Area RSS).
J. In events where SNS assets are deployed directly by the state to distribution sites within the Napa County Operational Area, communication will be between the State RSS (not the Op Area RSS) and the HHSA DOC and Op Area EOC, utilizing California Public Health and Medical Emergency Operations Manual resource requesting systems and RIMS. In such an event, a representative from Napa County will process orders to local PODs.
K. The County may have declared a disaster for the Operational Area and will request mutual aid from the Region. The most likely need will be for law enforcement mutual aid to assist in maintaining order and providing security for SNS assets. If regional mutual aid is insufficient, the state may send State Law Enforcement Officers and/or the National Guard. If several areas of the state are impacted, the County must be prepared to expand security on its own.
L. Alternative transportation routes may be required during periods of roadway congestion. The declaration of local emergency may include authority for restricting traffic.
M. City and County staff and volunteers who have been identified in advance will be called to implement the plan.
N. The Board of Supervisors issues a local proclamation, providing legal immunities for OA RSS activities.
O. The HHSA DOC and the Op Area EOC are activated.
P. Additional SNS background material is contained in Section 10.
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2. CONCEPT OF OPERATIONS
This plan is a part of the Napa County Health and Human Services Agency Concept of Operations Plan, which is an annex to the Napa County Emergency Operations Plan (EOP). In accordance with the EOP (sections 1-4), the California Standardized Emergency Management System (SEMS) and the National Incident Management System (NIMS) will be used for the implementation of this Strategic National and State Stockpile Plan and the management of the procedures that make up the plan.
The Op Area EOC is the lead agency for coordination and logistics for SNS receipt and distribution and Op Area RSS set up and management. The Napa County Health and Human Services Agency – Public Health has prepared the SNS Plan and is responsible for periodic review of the document, training in responsibilities, and, with the Operational Area OES, the exercising of this plan. Other County agencies and departments perform support functions as assigned in the Operational Area Emergency Operations Plan (EOP).
This plan is contained as Appendix 3 to the NCHHSA Concept of Operations Plan (CONPLAN), Annex H of the Napa County Emergency Operations Plan (CONPLAN), Annex H of Napa County Emergency Operations Plan.
An event requiring the request for the Strategic National and State Stockpile will trigger an activation of the Health and Human Services Agency Department Operations Center (HHSA DOC) and the Operational Area Emergency Operations Center (Op Area EOC), using the Standardized Emergency Management System (SEMS) command and control structure and principles of Unified Command.
The Op Area EOC Logistics Section will coordinate the logistical requirements associated with SNS receipt, storing, staging and distribution to PODs from the Op Area RSS.
The HHSA DOC manages and coordinates POD activation including clinical staffing, is the point of contact between PODs and SNS needs, determines SNS allocations to PODs, sends SNS distribution orders to the Op Area RSS, and prepares risk communications materials.
Points of Distribution (PODs) order prophylaxis directly from the HHSA DOC. The Medical Health Operations Area Coordinator (MHOAC) may designate the HHSA DOC Logistics Section Chief or other position to communicatewith the Regional Disaster Medical Health Coordinator or Specialist (RDMHC/S) for ordering and inventory replacement, utilizing SEMS, and returning unused supplies when the emergency response operations are ended by HHSA DOC.
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The HHSA DOC Logistics maintains up-to-date lists of contact information for personnel who would be notified to respond to a public health emergency.
Similarly, the State of California has instituted a “one-stop-shopping” number for use by key jurisdictional contact persons during emergencies. The OES Warning Center is available at all times to take calls and put local agencies in touch with representatives from State agencies. For this reason, local and state key contact lists in this document refer to these dispatch centers, rather than listing contact information for individuals. Under SEMS, State, rather than local, officials contact Federal agencies for assistance. The exception to this is the local FBI field office, which should be called by Napa County Sheriff’s Office to initiate a criminal investigation if a bioterrorism incident is suspected. Each County department maintains a list of contact information for their personnel. If persons identified as Unit Leaders of functions in this document are unable to serve, procedures are in place for designation of another person from the same department to fill the role.
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3. OPERATIONAL AREA RSS ORGANIZATION
Figure 1
EOC Resources Operational Area RSS Organization Branch Op Area EOC (for OA RSS Supplies/ Logistics Section Chief Equipment) Napa County Operational Area Receiving, Storing EOC Human Resources and Staging (OA RSS) Branch Organization Chart (for OA RSS Staffing) OA RSS Branch Director
Safety Officer
Materiel Transportation Communications Security Unit Unit Leader Unit Leader Unit Leader Leader
RSS Traffic Inventory Control Control Vehicle Communications/ Personnel Personnel Dispatcher IS Coordinator
Security for Receiving Drivers OA RSS Facility Personnel
Security for SNS Transport Sorting/Storing
Personnel
Staging/Quality Control Personnel
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3.1 OP AREA RSS ORGANIZATION ROLES AND RESPONSIBILITIES
POSITION RESPONSIBILITIES Point-of-contact between HHSA DOC & RSS. Mobilize and Op Area EOC Logistics Section oversee RSS operations. Manage/oversee the resource Chief requesting process (including requesting of human resources).
Supervise RSS Warehouse operations. Reports to Logistics Op Area RSS Branch Director Section Chief. With the Op Area Logistics Chief, determine warehouse staffing needs. Ensure equipment and supplies needed to operate RSS Warehouse are obtained and utilized appropriately.
Identify staff to fill Op Area RSS positions. Notify staff to Op Area EOC Logistics Section/ report to the Op Area RSS. Provide list of authorized RSS staff Human Resources Unit for RSS sign-in and security check points. Provide on-going human resources support to OA RSS staff.
Coordinate medical/health resource requests using the HHSA DOC Logistics Section California Public Health and Medical Emergency Operations Chief Manual (EOM) resource request form (in conjunction with the EOC Logistics Chief). Resource requests are submitted to both the RDMHC program and the Napa County Office of Emergency Services (or the EOC, if activated). Resource requests should be entered into RIMS at the Operational Area level.
Prepare RSS Warehouse to process expected SNS shipment. Op Area RSS Materiel Unit Obtain equipment and non-medical supplies necessary to support the OA RSS (forklifts, pallets, tables, etc.). Responsible for receiving, sorting, storing, staging, quality control and inventory control functions.
Deploy/assign transportation assets to meet needs of Op Area RSS Transportation delivery, supply and re-supply to PODs. May coordinate Unit transportation to pick up SNS from a state location. Provide fencing, barricades, traffic barriers, and temporary building modifications for the OA RSS, as required.
Set-up, manage and maintain communication equipment at Op Area RSS Communications the OA RSS as required. Maintain contact list of all RSS staff. Unit
Assign local law enforcement resources and assets to security Op Area RSS Security Unit concerns, sites, and situations. Conduct security sweep of
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POSITION RESPONSIBILITIES RSS. Provide security escort to SNS/POD delivery vehicles. Assist to identify alternate delivery routes. Close roads to non-emergency traffic to maintain delivery routes.
For large scale response, ensure equipment and supplies EOC Logistics Resources Branch needed to operate RSS are delivered to Warehouse.
Prepare situation reports once per operational period, per HHSA DOC Planning Section the California Public Health and Medical Emergency Chief Operations Manual. Forward situation reports to the RDMHCs, CDPH and EMSA duty officeers (or JEOC if activated), and the county EOC director.
4. REQUESTING THE STRATEGIC NATIONAL AND STATESTOCKPILE
If Napa County anticipates or experiences an unusually high incidence of sickness or death that threatens to overwhelm its ability to respond, it will request additional resources following procedures outlined in the California Public Health and Medical Emergency Operations Manual (EOM). If resources within the Operational Area are insufficient to meet response needs, the Medical Health Operational Area Coordinator (MHOAC) will request additional resources from the Regional Disaster Medical Health Coordinator or Specialist (RDMHC or RDMHS). The RDMHC/S supports the Operational Area by coordinating the medical mutual aid response within the Region. If there are insufficient resources within the Region, the RDMHC will contact the State Emergency Medical Services Authority to request medical resources from other Regions. If in-state resources are insufficient, the Governor will contact the director of the CDC to request the Strategic National Stockpile. Resource requests are submitted to both the RDMHC program and the Napa County Office of Emergency Services (or the EOC, if activated). Resource requests should be entered into RIMS at the Operational Area level. The following steps are involved in the decision process:
4.1 DETECTION
The decision to request the SNS begins with data from the following sources:
Data collected from an epidemiological investigation
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Field or intelligence reports from law enforcement that provide evidence that a biologic agent release has occurred
Intelligence reports from law enforcement of a credible threat of the impending release of a biologic or chemical agent
A neighboring county reports that a public health outbreak has occurred that may significantly affect Napa County.
The need for the SNS may be identified gradually as public health officials determine the magnitude of the public health emergency, and that the local inventory of pharmaceuticals and medical supplies will be insufficient to meet the anticipated demand.
4.2 INVESTIGATION
Epidemiological investigation in accordance with state and local epidemiological response plans will be applied to assist in identification and confirmation of an event.
4.3 CONSULTATION
Once initial information is available officials need to discuss the situation. This may include, but is not limited to representatives from the following agencies:
Napa County Health and Human Services Agency
Napa County Office of Emergency Services
The Governor’s Office of Emergency Services
California Department of Public Health personnel, such as:
o State Health Officer
o State Communicable Disease Epidemiologist
Executive Director of the State Board of Pharmacy
California Emergency Medical Services Authority
U.S. Centers for Disease Control and Prevention (CDC)
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Other agencies may be included in the consultation, as appropriate. Due to the urgency of the situation, consultation will not be delayed if some officials are not available to participate.
4.4 REQUESTING THE SNS
In accordance with SEMS/NIMS, MHOAC program staff will request SNS resources through California’s Medical /Health Mutual Aid System when it is anticipated that Operational Area resources are inadequate or will be depleted. Requests may be made by the Health Officer, who is Napa County’s Medical Health Operational Area Coordinator, or by designated MHOAC program staff, such as the Logistics Section Chief. Requests are made to the Regional Disaster Medical/Health Coordinator/Specialist (RDMHC/S). The MHOAC and designees will follow the procedures outlined in the California Public Health and Medical Emergency Operations Manual to request assistance with health and medical assets, as described in the county’s CON PLAN. The MHOAC has designated the Plans Section Chief to complete and submit the Medical and Health Situation Report (described in the county’s CON PLAN) to the Regional Disaster Medical Health Coordinator/Specialist and/or CDPH/EMSA duty officers as appropriate.
If the MHOAC or his/her designee determines that additional SNS assets are required, he/she will request additional resources utilizing the same procedures to request SNS assets as outlined in the EOM.
MHOAC and Alternate MHOAC:
Title Name Title/Position Location Phone
Health Officer Dr. Karen Smith Health Officer HHSA/PHD 253-4270
DOC Director X*X*X*X*XX*X* X*X*X*X*X*X**X*X
4.5 ACCESSING LOCAL, REGIONAL AND STATE RESOURCES
If Regional resources are depleted or delayed, the RDMHC would forward the request to the State. The Joint CDPH/EMSA Medical/Health Emergency Operations Center (JEOC) will process the request.
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If in-state resources could not fulfill the request in a timely manner, the JEOC would request the SNS through the State Emergency Operations Center (SOC) at the Governor’s Office of Emergency Services (OES). The Governor, acting through OES, would request the SNS directly from the Centers for Disease Control and Prevention (CDC).
Before deploying the SNS, CDC will assess available information about the threat and the ability of state and local authorities to respond. Once it determines that the threat is valid and substantial, having received a formal request from the Governor or his/her designated representative, CDC would approve deployment of the SNS.
Figure 2 on the following page summarizes the process for requesting the SNS in California. The Medical and Health SIT REP form that the MHOAC program (Planning Section Chief) completes and forwards to the RDMHC/S is available online in the Napa County HHSA network at G:\!!Disaster DOC (Department Operations Center) folder.
As soon as the decision is made to request the SNS, key contacts in Napa County will be notified and the remainder of this plan will be activated in preparation for receiving the SNS. Local, State and Federal contact information is located on the page following Figure 2.
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Figure 2: Medical/Health Resource Request, Notification, Coordination Flow Chart
Resource GOVERNOR Call then goes to Centers for Disease or Request Control and Prevention/ Designee Strategic National Resource Stockpile (SNS) Program Black Text & Line shows OES Reporting Request
Red Text and Line OHS/OES/CDHS shows M edical Health Requests/Notifications DIRECTORS
OES Executive Duty Officer
(EDO) M H OAC = Medical STATE OES WAR N ING CENTER Health Operational OES SOC DO / JEOC
Area Coordinato r RE OC DO CDPH/EMSA
OER/US Public Health RDMHC = Regional Service Resource Disaster Medical Health Coordinator Request CDPH DUTY OFFICER
CDPH Emergency Preparedness RDMHS = Regional Disaster Medical RDMHC Health Specialist staff to the RDMHC
Notification Resource Notification Request OES EOC ** County Emergency CDPH Division of Operations Cent er Communicable
Disease Duty Officer County Public Health Division MHOAC
Federal Bureau of Pu b lic Health Office r Investigation Resource Reques t
RDMHC Consultation ** County Pu blic Health RDMHS or EOC notifie s
DISEASE OUTBREAK DETECTED potentially af fected cities within the County
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4.6 RECEIVING, STORING AND STAGING (RSS) THE STOCKPILE
The State will deliver the Strategic National and State Stockpile to the Receive Store and Stage (RSS) Warehouse, which will be made ready to receive the SNS. The effectiveness of the RSS operation will significantly determine the speed with which the public receives protective medicines, and treatment centers receive the supplies they need to treat the sick.
4.7 STATE TRANSFER OF RESOURCES
The CDC requires that a State Official designated in the State’s SNS Plan sign for custody of SNS materiel upon delivery to the State RSS Warehouse site. The Drug Enforcement Agency (DEA) Registrant signs for controlled substances. The State provides the CDC with a list of authorized State officials that can sign for the SNS. This list can also be found in the State SNS Plan.
4.7.1 DESIGNATED OPERATIONAL AREA OFFICIALS
A designated official from the County will sign for custody of the medical resources provided in the Operational Area. In Napa County, the designated official is the Health Officer or designee.
The Health Officer (or designee) and local DEA agent sign for custody of the allotted SNS materiel and any Scheduled II through V controlled substances. NOTE: Transfer of Schedule II drugs requires that a DEA Form 222 be utilized.
The Public Health Officer, who is a DEA registrant, has legal authority to sign for and receive portions of the stockpile. In the absence of the Health Officer, the interim Health Officer, the RSS Branch Leader or designee has the authority to sign for the SNS, on behalf of the DEA registrant, and the registrant will co-sign as soon as possible.
4.7.2 TRANSFER DOCUMENTS
The County will sign the appropriate forms for acceptance of the allotted SNS materiel. A copy of the following form is included as Section 9 page 41.
Custody Transfer Form (State-Local)
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4.8 RSS WAREHOUSE
RSS Warehouse operations are described in the Napa County SNS Field Operations Guide.
The RSS Warehouse ensures the proper storage, handling, security and transfer of controlled substances and medical equipment/supplies while they are in the custody of the warehouse. Napa County has designated a warehouse to distribute the SNS. The location is confidential, to protect the materiel and the public.
If additional office space is needed, RSS administrative functions can operate out of the offices of the Napa County Fire/California Division of Forestry and Fire Prevention (NCF/CDF) or the Napa Sheriff’s Office.
4.9 RSS WAREHOUSE FUNCTIONS
The functions within the RSS Warehouse are designed to Receive, Sort, Store, Inventory, Stage, Quality Control and Dispatch/Delivery of SNS materiel.
4.9.1 RECEIVE
Receiving involves formally accepting custody of SNS materiel from the CDC by signing forms presented by the CDC or the State, including acceptance of responsibility for controlled substances and/or medical equipment/supplies.
The County must assume the responsibility of physically offloading the SNS materiel from the aircraft or ground transportation vehicles. Logistics Section of the Op Area EOC will provide equipment for off-loading and moving the SNS.
The CDC estimates that it will take approximately one hour for one forklift to offload one truck. Each forklift driver must be supported by two additional people – one to position the containers at the end of the truck, and one to roll the containers from the forklift to their storage location in the warehouse. The size of a delivery will vary.
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4.9.2 MANAGING CONTROLLED SUBSTANCES
A 12-hour Push Package currently includes three different controlled substances: morphine, diazepam, and midazoliam. The Drug Enforcement Administration (DEA) classifies substances by their potential for abuse. Accordingly, morphine is classified as Schedule C-II, while diazepam and midazoliam are classified as Schedule C-IV.
The DEA regulates the storage and transfer in accordance with Title 21 of the U.S. Code of Federal Regulations. The DEA subsequently authorizes individuals (registrants) to handle specific classes of controlled substances. The registrants must ensure that they maintain a detailed chain-of-custody record of all transfers. For C-II substances, that record must include a DEA Form 222 that the person who receives the materiel initiates to request the transfer.
The DEA recognizes that during an emergency, availability of the identified DEA registrant may be limited. If the identified DEA registrant is unavailable to accept receipt at the time of delivery, the DEA will still allow delivery of the controlled substance to the organization, but the registrant must eventually provide signed paperwork for each transfer.
An SNS Push Package contains lorazepam, valium, and morphine, diazepam, morphine, and midazolam which will be delivered in DEA approved locked containers with hardened sides. There is a chain link fence inside the container, which is shipped with the hardware necessary to bolt it to a post.
A chain-of-custody for the controlled substances is maintained throughout each phase of the SNS deployment. Security measures to minimize potential for diverting SNS controlled substances will be ensured by the Security Unit Leader.
4.9.3 REPACKAGING OF BULK MEDICATIONS
SNS bulk medications will be repackaged by the State before they are shipped to local jurisdictions. Should the County decide to purchase a local cache of antibiotics, we will address repackaging issues.
4.10 SORT AND STORE
If we receive CDC cargo containers or pallets, they should be stored by product type and then sequentially by container/pallet number to make it easy to find containers/pallets that hold specific products. The color of the document pouch cover on the side of each container/pallet identifies the type of product it holds:
Yellow – Injectables (IV supplies and fluids)
Red -- Oral medications
Blue – Airway management
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Clear – Medical/Surgical supplies
Markings on the top of three sides of the container/pallet will prominently identify its serial number. The container’s/pallet’s document pouch will contain a list of the container’s/pallet’s contents (and a diagram of the position of products inside the container, if containers are received).
In storage, containers/pallets should face into an aisle so warehouse staff can easily remove the container’s/pallet’s contents. Aisles between rows of containers/pallets should be wide enough so staff can easily move an entire container/pallet manually or by forklift to the staging area.
4.10.1 MATERIEL STORAGE AND HANDLING
Allotted medical resources in staging, storage and in transit must remain at appropriate temperatures to ensure its potency. Some items in the SNS materiel require refrigeration: arrangements should be made to have them shipped in appropriate refrigerated or insulated cold shipping/storage containers.
4.10.2 ENVIRONMENTAL
SNS materiel must remain at appropriate temperatures during staging, storage and transportation to ensure its potency. It is essential to keep most SNS materiel at controlled room temperatures, between 59ºF and 86ºF. This means storage sites, dispensing sites, treatment centers and distribution vehicles must all be able to maintain this temperature range during very hot or very cold periods. Materiel should not be left outside during these periods. Currently, no items in the 12-hour Push Packages require refrigeration.
4.11 STAGING AND QUALITY CONTROL
The HHSA DOC and the RSS Branch Director direct the inventory control function to be distributed to PODs. The Staging/Quality Control function receives distribution orders, and pulls SNS materiel accordingly, preparing it for transport from the Local RSS Warehouse to PODs/dispensing sites and treatment centers. Quality Control function reviews the orders and items to ensure materiel pulled matches distribution documents. If the Local RSS Warehouse is not activated, the inventory control function is managed from the HHSA DOC and SEMS is used to direct the materiel to the PODs/dispensing sites and treatment centers.
As the inventory control function issues materiel order forms, it will monitor the stocks on hand and provide reports to HHSA DOC for management decision making needs.
4.12 DISPATCH/DELIVERY
The Transportation Unit oversees the Dispatch and Delivery functions of SNS materiel. Once the SNS materiel is ready for distribution, Dispatch and Delivery personnel ensure safe delivery of materiel, in coordination with Security Unit for escort.
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 16 ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 4.13 OA RSS STAFFING
Management personnel of the OA RSS include:
RSS Branch Director signs the Custody Transfer Form for receipt of the SNS materials. This position reports to Op Area EOC Logistics Chief.
Safety Officer (is assigned from Op Area EOC Safety) ensures safety considerations are part of continuing staging operations, completes accident investigations.
Materiel Unit Leader (reports to RSS Staging Branch Director), oversees Receiving, Sorting, Storing, Staging and Quality Control processes and Inventory personnel.
Transportation Unit Leader (reports to RSS Staging Branch Director, Op Area EOC Transportation Unit) oversees Dispatch and Drivers.
Communications Unit Leader (reports to RSS Staging Branch Director, Op Area Logistics Section/Communications),
Security Unit Leader (reports to Law Enforcement Branch Director at the Op Area EOC),
Position checklists are listed in Section 7. See Organizational chart page
4.13.1 STAFFING OA RSS
The OA Logistics Section Chief, with assistance from Human Resources Branch, identifies Napa County staff to fill the above positions for 24 hour shifts. If Napa County’s staffing resources become insufficient, potential sources from local government or volunteer staff include: County and City Fire Overhead Management Team members ( most have fire staging experience) City and County Transportation Managers County Public Health Division Pharmacies County Communications Team Disaster Service Workers, City and County California National Guard Community Emergency Response Team (CERT) California Department of Forestry
The county has an agreement with the Napa County Jail to provide meals for responding RSS Staff. All responding staff will follow established county policies regarding compensation, break/lunch and work shifts unless otherwise noted by the CEO.
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 17 ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 4.14 OA RSS DISTRIBUTION AND TRANSPORTATION OF RESOURCES
A. The State has primary responsibility for distributing SNS assets to OA RSS Warehouse and/or dispensing sites/treatment centers. However, if state resources are unavailable, the OA will be expected to augment this distribution process.
B. The primary method of transporting materiel from the OA RSS Warehouse to the delivery points will be by trucks. Alternative methods may include helicopters, cars, etc. The main delivery points to PODs/dispensing are contained in the Countermeasure Distribution Plan, (Annex H, Appendix 4 of the Napa County Emergency Operations Plan). Other potential delivery points include hospitals, clinics, pharmacies, long term care facilities, assisted living facilities, and other medical and mental health institutions identified.
C. Tracking resources throughout the process is a very important step in determining what assets are needed in the affected area. Routine reports on the status of deliveries are made to the OA RSS Materiel Unit Leader, which are reported to HHSA DOC.
D. Transportation of materiel to the delivery points will follow routes delineated by the Security Unit Leader and/or local law enforcement. Routes may be pre-delineated by cities as POD sites/dispensing sites are identified. Or, routes may be delineated by the Op Area EOC Operations Section, Law Enforcement Group upon activation of mass prophylaxis and receipt of the SNS.
The OA Logistics Section maintains listings of available transportation resources for use in SNS OA RSS to POD distribution. Transportation resource considerations are:
Trucks: full size pickups or larger with restraining straps, hydraulic lifts, maintain temp at 59°- 86°, communications devices to PODs and staging, drivers (with badges),
Helicopters: slings for carrying, ground to air communication with pilots, maintain temp at 59°- 86°
Fuel 24/7: drivers with credit cards
Repair and maintenance 24/7
Dispatch
Situations when Hospitals, first responders, other essential personnel, and/or POD facility representatives requested to send a representative to receive and transport needed supplies or equipment to their facilities.
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 18 ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 4.15 OA RSS CREDENTIALS/BADGING FOR ENTRY TO THE RSS SITE
All personnel assigned to RSS Warehouse duties are required to bring and wear their Napa County ID badge for identification during the SNS RSS Warehouse and transportation operations. Napa County ID Badges are required for entry to the RSS Warehouse Area for all RSS personnel, Napa County OES and HHSA DOC, or other Napa County staff with RSS duty assignments or coordination responsibilities requiring visits to the RSS. All staff must show their Napa County ID badge at security checkpoints and sign-in and out.
The HHSA DOC and Operational Area EOC Logistics will maintain a list of authorized personnel for check-in at RSS Warehouse, and provide the Authorized Personnel list to Op Area RSS Branch Director and Op Area Security Unit. Note: Delivery vehicles under state control will be pre-identified prior to entry to the OA RSS site, using other pertinent information.
Delivery vehicles under state control will be pre-identified prior to entry to the OA RSS site.
4.16 SECURITY FOR THE OA RSS SITE, TRANSPORTATION, AND POINTS OF DISTRIBUTION
A. Key security considerations for securing the OA RSS Warehouse include:
Controlling access into, within and out of the facility
Perimeter protection
Establishing and protecting Landing Zones
Crowd control.
B. Key considerations for securing the PODs/dispensing sites and treatment centers include:
Traffic control
Crowd control
Establishing and protecting Landing Zones
Protection of staff, materiel, and equipment.
C. As with most emergencies, law enforcement staff assigned to the following operations will be on a 12-hour shift plan.
D. The Sheriff’s Office will maintain security at the OA RSS and for security during transport of pharmaceuticals to the Points of Distribution (PODs).
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 19 ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 E. The Sheriff’s Office will follow their operating and use of force guidelines and policies.
F. As PODs are activated, each jurisdiction is responsible for providing security to the PODs located in their area of responsibility Agencies that request help with POD security shall be supplemented with personnel by the Sheriff’s Office and the Mutual Aid system.
G. During the emergency, a mobile field force should be staffed and maintained at the ready to respond to civil disruptions at the PODs or the OA RSS, following standard policies on use of force.
H. Should this County’s law enforcement resources be depleted, the Mutual Aid request will follow current protocol for more resources.
I. There may be a use for private security agencies.
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 20 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014
4.17 OA RSS COMMUNICATIONS
Effective tactical communications during an event is critical to the continual and timely flow of materiel to dispensing sites, treatment centers, and other locations. Communications includes the following:
The operations to oversee the county OA RSS Warehouse distribution system and provide timely status reports to the event HHSA DOC and Op Area EOC,
Driver reports of deliveries and en route problems,
Orders from dispensing sites and treatment centers for materiel, and
Coordination with law enforcement for protection and traffic/crowd control.
Communication requirements for staging and delivery operations are:
Delivery truck drivers must be able to talk with Materiel Unit, Transportation Unit Leader and PODs.
Materiel Unit must be able to talk with the Op Area EOC and HHSA DOC.
HHSA DOC must be able to communicate with the State RSS, CDPH EOC, Op Area EOC, RSS Warehouse Units and PODs.
RSS Security Unit must be able to talk with the Op Area EOC Law Enforcement Branch.
The primary means of communication is existing phone lines at the Op Area EOC, the HHSA DOC, the OA RSS Warehouse and at PODs/dispensing sites and/or treatment centers. The Op Area EOC Logistics Section is responsible for coordinating set up of communications equipment and systems at (radios, telephones, 2-way cellular phones, Internet connections, e-mail, etc) to the OA RSS Warehouse and PODs/dispensing sites and/or treatment sites. Communications equipment and systems may include:
Radios, including RACES equipment and operators
Satellite telephones
Telephones
Cellular telephones and 2-way cellular (Nextel) phones
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 21 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014 Laptop and desktop computers
Internet connections and e-mail
Fax and copy machines
The HHSA DOC has access to a satellite telephone that is used if land-based telephone systems are non-functional or overloaded. The satellite telephone functions independent of telephone lines and is designed to communicate with either normal telephones or other satellite telephones. The satellite telephone is located in the HHSA campus, building G and may be utilized when other modes of communication are not available.
All emergency First Responders have radio communications.
All Local RSS Warehouse transport vehicles will have communications equipment which may include radios, cell phones, etc.
Communications with hospitals will occur through existing phones lines. HAM radios will serve as a backup method of communicating with hospitals.
5. OA RSS INVENTORY CONTROL AND TRACKING
Tracking of SNS assets and inventory control is required throughout the receiving, delivery and distribution process. Tracking usage rate is important for timely re-supply. A combination of paper and electronic tracking system is available for use.
The paper tracking component consists of:
Receiving and RSS Storage tracking: SNS Receiving Verification form
SNS Distribution tracking: Distribution Pick List form
The electronic tracking component includes:
SNS Order Summary Log
RSS Inventory Summary Log
Inventory Distribution Summary Log
POD worksheets
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 22 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014 The electronic tracking system and forms are managed by HHSA DOC and Public Health Division. Copies of the paper forms are located in Section 9.
SNS initial receiving information includes:
Pharmaceutical or equipment item(s) name,
Pharmaceutical or equipment item(s) NDC Product identification number,
Quantity of boxes,
Boxes contents ( 6- 500ml bottles, or 12 – 100 tablet bottles),
Product Lot Numbers,
Date and Time, and
Product’s storage location at the RSS Warehouse.
Unused materiel: Once the RSS Warehouse operations are ended, the Materiel Unit Leader will enlist the support of the CDPH, State RSS Warehouse and TARU officials that are available to ensure that all unused medical resources are accounted for and, where appropriate, returned to the State RSS Warehouse. The Transportation Unit Leader will assist in the movement of returned materiel to the State RSS Warehouse.
5.1 NON-MEDICAL SUPPLIES
Op Area EOC Logistics Section assists with obtaining supplies and equipment needed to support the local RSS operation. A RSS Set-up Supplies and Equipment Checklist is located in Section 6, page 23.
6. OPERATIONAL AREA OFFICIALS AUTHORIZED TO SIGN FOR THE SNS
Title Name Title/Position Location Phone
Health Officer Dr. Karen Smith Health Officer HHSA/PHD 253-4270
DEA Registrant Dr. Zoe Martinez Psychiatric Medical HHSA/PHD 259-8167 Director
DEA Registrant Dr. Victor Aaen Interim Health Officer Veteran’s 944-4847 Home
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 23 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014 7. RSS WAREHOUSE SET UP EQUIPMENT & SUPPLIES LIST
(Assess Need Prior to SNS Delivery)
ITEM DESCRIPTION QTY AVAILABLE AT SITE DELIVERED BY EOC
COMMUNICATIONS and IT EQUIPMENT:
Handheld radios & headsets w/ chargers
AM/FM radio for news
Laptop Computers
Computer Cables
Fax/copier/printer (with extra refill cartridge)
Portable generator
Power Strips with circuit breakers (heavy duty)
Extension Cords – 2, 25ft., 2, 50ft., 2, 100ft. (10 to 12 gauge copper)
Other:______
MATERIEL HANDLING EQUIPMENT and SUPPLIES:
Forklift – 3000-5000 lb capacity
Fuel for forklifts & generators
Hand trucks – multipurpose
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 24 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014
ITEM DESCRIPTION QTY AVAILABLE AT SITE DELIVERED BY EOC
Refrigerator(s) 20 cu. Ft if needed
Pallet jacks
Pallets (# Needed for each SNS Order)
Flashlights and batteries
Stretch Wrap
Toolbox with standard tools for emergency repairs.
Rolls of 3” color tape (4 colors each) for Warehouse layout and traffic control
Cones, traffic
Maps, streets (Thomas Guides)
Ear Plugs (200/box)
Back Support Belts
Leather Gloves (work type)
HYGIENE-RELATED SUPPLIES:
Hygiene supplies (soap, hand gel, t.p., paper towels)
Brooms, dust pans
55-gallon trash cans on rollers and liners
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 25 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014
ITEM DESCRIPTION QTY AVAILABLE AT SITE DELIVERED BY EOC
OFFICE EQUIPMENT & SUPPLIES:
Situation Board for monitoring transportation and delivery of SNS materiel
Tables, folding or stacking
Chairs, folding or stackable
Portable fans (36” minimum)
Colored markers
Highlighter markers
Pens, black ink
Paper, lined tablets
Paper, copy-blank
Scissors
Staplers & Staples
Papers clips, large
Binder clips, medium & large
Tape, Scotch ½”
Clipboards
Black markers
First Aid kit
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 26 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014
8. POSITION CHECKLISTS FOR RSS PERSONNEL
8.1 OP AREA RSS BRANCH DIRECTOR
Manage the OA RSS operations area and has the authority to sign for receipt of the SNS. Oversee the RSS operations including transportation, communication, security, and materiel management. The OS RSS Branch Director is assigned by and reports to the Logistics Section Chief at the Op Area EOC. Op Area RSS –BRANCH DIRECTOR CHECKLIST
Report and sign-in at OA RSS Warehouse.
Establish and maintain briefing schedules with management staff as necessary.
Sign for transfer of SBS materiel received. If not a DEA registrant, have Public Health Officer or other DEA Registrant re-sign for controlled substances.
Provide briefing/status on RSS operations to the Op Area EOC Logistics Section Chief
Monitor and coordinate efforts of all RSS functional areas. Assist flow between those functional areas and mutual support across functions.
Interact with Op Area EOC Logistics to request support from other Op Area EOC Branches.
Coordinate with Op Area EOC Health and Medical Branch/HHSA DOC to receive status of POD activity: numbers of people prophylaxed, flow information, rate of use, etc. Share with RSS staff for projection of hours, staffing requirements, transportation capacity, etc.
Maintain contact with the MHOAC in relation to allocation of limited medical resources to PODs and/or treatment sites. (i.e. ventilators, medical / surgical equipment, vaccines, pharmaceuticals, etc.). Discuss with Materiel Unit Leader and PH Nurse as appropriate.
Maintain documentation of costs, including equipment; overtime labor hours, and mileage.
At a shift change, provide a detailed status report and written materials to next shift staff.
Ensure that OA RSS Staff participate in demobilization of the RSS Warehouse.
Ensure the collection and return of all unused medical resources, including those resources sent to PODs and/or treatment centers.
Collect all summary reports and documents from RSS staff for debriefing and final documentation of operation.
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8.2 OP AREA RSS MATERIEL UNIT LEADER
Oversee Receiving, Shipping, Inventory, and Movement. The OA RSS Materiel Unit Leader reports to the OA RSS Branch Director. Coordinate with Transportation, Communication and Security Unit Leaders.
Op Area RSS – MATERIEL UNIT LEADER CHECKLIST
Report and sign-in at OA RSS Warehouse.
Attend initial briefing with Branch Director.
Determine extent of staffing required for Materiel operation. How many PODs are established, number of transport vehicles available/needed, hours of POD operation, hours of RSS operation, expected days of prophylaxis campaign.
Coordinate with Op Area EOC Human Resources Branch for additional staffing for Group.
Provide staffing for all shifts.
Review checklists of Receiving, Inventory Control and Staging/QC personnel. Ensure all positions are covered and provide Just-In-Time Training as needed.
Assist all materiel coordinators in performance of their functions. Assist with coordination with other RSS Groups; ensure resources are available to complete the mission.
Ensure documentation completed accurately for receiving and distribution functions of SNS materiel (SNS Receiving Verification and Distribution – Pick Lists).
Work with Transportation and the Inventory Control Personnel to develop delivery schedules for POD routes.
Coordinate with Security on lapses or suspicious instances in product movement.
Provide information during briefings and to the RSS Branch Director regarding product use, inventory levels, re-supply schedule, etc.
Maintain documentation of response costs, including equipment; overtime labor hours, and mileage.
At a shift change, provide a detailed status report and all written materials to replacement staff.
Ensure all materiel functions participate in the demobilization of the Staging Area, and gather, inventory, pack and ship all unused product for return. Identify and tag all product and equipment needing repair.
Provide a summary report to the OA RSS Branch Director for documentation and debriefing.
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 28 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014
8.3 RSS INVENTORY CONTROL PERSONNEL
Maintain information on inventory status to determine re-supply strategies. Oversee the re-packaging of bulk packages, if required. The Inventory Personnel reports to the RSS Materiel Group Leader. Coordinate with Receiving, Shipping, Transportation and RSS Branch Director, MHOAC and HHSA DOC.
Op Area RSS – INVENTORY CONTROL PERSONNEL CHECKLIST
Report and sign-in at OA RSS Warehouse.
Report to Materiel Unit Supervisor.
Participate in initial briefing. Receive information on the request of SNS, products ordered, expected timeframe, etc.
Receive Just-In-Time Training and Safety Plan training.
Receive SNS Order from HHSA DOC. Enter information into Inventory Control Tracking System, IICTS) and issue SNS Receiving Verification form, giving to Receiving Group in Materiel Unit to process.
Obtain completed SNS Receiving Verification form to Receiving Group, with RSS location and Lot numbers. Enter this additional data into ICTS, to assist tracking materiel. File document(s) for future reimbursement and event tracking purposes.
Receive POD Order forms from HHSA DOC, and issue Distribution-Pick Lists for each POD order, giving to Staging Group in Materiel Unit to process.
Obtain completed Distribution-Pick List, checking the product Lot numbers and orders were distributed as issued. File forms for future reimbursement and event tracking purposes.
Routinely check inventory levels of medications and supplies, notifying Materiel Unit Leader.
Ensure the Inventory Control Tracking System data is current and accurate. Double check all entries once entered, for accuracy. Save electronic system regularly, and make back-up copy onto a CD/other source at end of each shift (in case of power failure or e-system failures).
Maintain documentation of personnel time, including operating equipment and supplies used during shift.
At a shift change, provide a detailed status report and all written materials to Materiel Unit Leader.
During the demobilization of the RSS Warehouse, obtain returned inventory counts for all unused items.
Make personnel needs known to Materiel Unit Leader during any stage of operations when staffing, equipment or supplies insufficient to meet assignment activity.
Be prepared to provide Just-in-Time training at shift change to position replacement staff.
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8.4 RSS RECEIVING PERSONNEL
Reporting to the Materiel Unit Leader, Receiving personnel are responsible for the accurate documentation of incoming materiel and use of equipment to move materiel.
RSS WAREHOUSE - RECEIVING PERSONNEL CHECKLIST
Report and sign-in at the Op Area RSS Warehouse.
Report to Materiel Unit Leader.
Participate in initial briefing. Receive information on the request of SNS, products ordered, expected timeframe, etc.
Receive Just-In-Time Training and Safety Plan training.
Ensure fork lift or pallet jack is available to use.
Ensure work gloves, lifting belts are available and use them.
Work with Safety Officer to review safe fork lift and lifting procedures.
Obtain SNS Receiving Verification form from Inventory Control, to use to compare State SNS shipment received with SNS requested by HHSA DOC.
Obtain receiving documents from initial shipment. Verify contents of all containers, boxes and cartons. Report any discrepancies. Obtain Materiel Unit Leader’s signature on receiving documents and return forms to Inventory Control Group.
Coordinate/receive instruction from the Public Health Nurse on identification of product as necessary.
Determine location for temporary storage of each product. Clearly mark off the floor of the storage area.
With warehouse movers, relocate product to assigned temporary storage location.
As additional shipments are received: verify contents, prepare receiving documents for signature. Complete all receiving documents, obtain Materiel Unit Leader’s signature and return forms to Inventory Control Group.
In between incoming shipments, report to Materiel Unit Leader for temporary reassignment.
Prepare documentation of response costs, including equipment; overtime labor hours, and mileage, as appropriate.
At a shift change, provide a detailed status report and all written materials to Materiel Unit Leader. Sign-out to track your time.
During the demobilization of the Warehouse, receive all products from PODs and treatment centers, documenting inventory and providing report to Inventory Control Group.
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 30 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014
8.5 RSS SORTING AND STORING PERSONNEL
Reporting to the Materiel Unit Leader, Sorting and Storing personnel are responsible for the accurate documentation of sorting and storing the SNS materiel in the RSS Warehouse.
Op Area RSS – SORTING & STORING PERSONNEL CHECKLIST
Report and sign-in at OA RSS Warehouse.
Report to Materiel Unit Leader.
Participate in initial briefing. Receive information on the request of SNS, products ordered, expected timeframe, etc.
Receive Just-In-Time Training and Safety Plan training.
After the Receiving Group confirms the SNS shipment and transfers the SNS materiel to the Sorting/Storing Group, sort the shipment by same-type materiel and store in pre-designated areas. List storage location and Item Lot Numbers on the SNS Receiving Verification, and return completed form to Inventory Control.
Ensure product information is easily seen for distribution activities, and storage area is tidy.
Routinely inventory levels of medications, repackaging supplies and other materiel needed to maintain the operation.
Routinely track space available in the Storage Area.
Maintain documentation of personnel time, including operating equipment and supplies used.
At a shift change, provide a detailed status report and all written materials to Materiel Unit Leader.
During the demobilization of the RSS Warehouse, assist with the re-packaging, labeling and return of all unused items.
Make personnel needs known to Materiel Unit Leader during any stage of operations when staffing, equipment or supplies insufficient to meet assignment activity.
Make additional personnel needs known to Materiel Unit Leader.
Be prepared to be reassigned as needed to other assignments within the Warehouse.
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 31 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014
8.6 RSS STAGING/QUALITY CONTROL PERSONNEL
Staging/Quality Control personnel report to the Materiel Unit Leader, and are responsible for processing orders for PODs or other distribution sites; accurate picking of the orders; packaging the order for shipping.
OA RSS – STAGING/QUALITY CONTROL PERSONNEL CHECKLIST
Report and Sign-in at OA RSS Warehouse.
Report to the Materiel Unit Leader.
Participate in initial briefing. Receive information on the request of SNS, products ordered, expected timeframe, etc.
Receive Just-In-Time Training and Safety Plan training.
Receive Distribution-Pick List form from Inventory Control.
If assigned to Staging activities, receive Distribution Pick List and pick materiel for POD’s order and place on pallet(s). With warehouse movers, move pallet to Quality Control Area.
If assigned to Quality Control, review pallet materiel confirming Distribution Pick List form and materiel match. Then shrink wrap pallet, check –off Distribution Pick List and transfer materiel to Transportation Unit to arrange delivery by drivers.
Following the initial distribution to PODs, pick and stage orders for other delivery points (e.g. jails, skilled nursing facilities, home health agencies, etc.) as directed by Materiel Unit Leader.
The shipping section could be one of the most active, request additional staff from the Materiel Unit Leader.
Rotate empty containers to the back of staging area.
Maintain documentation of response costs, including equipment; overtime labor hours, and mileage, as appropriate.
At a shift change, provide a detailed status report and all written materials to Materiel Unit Leader and sign-out at EOC.
During the demobilization of the Warehouse, assist with the re-packaging and return of all unused items, providing documentation to Inventory Control Group.
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8.7 OP AREA RSS TRANSPORTATION UNIT LEADER
Coordinate transportation and all movement of materiel, including initial shipment, re-supply shipments, and movement from the RSS Staging area to PODs or other delivery sites. The OA RSS Transportation Unit Leader reports to the OA RSS Branch Director. Coordinate with the Op Area EOC Logistics Section Transportation Branch. Op Area RSS - TRANSPORTATION UNIT LEADER CHECKLIST Report and Sign-in at OA RSS Warehouse. Coordinate with Public Health HHSA DOC or Op Area EOC to obtain addresses of PODs. Ensure maps are available for all drivers: coordinate with Op Area EOC Equipment and Supplies. Review routes to be driven with drivers; consider traffic, security, weather, & road conditions. Provide updates to the management team regarding transportation issues at briefings. Establish and maintain contact with Op Area EOC Logistics Section/ Transportation Branch to request additional vehicles and personnel resources and to provide status reports. Inspect vehicles to be used for delivery to ensure temperature controls (if required) are sufficient. Ensure all drivers have obtained badges to permit their entry to the RSS Warehouse area. Work with the Inventory Control Personnel to establish delivery schedules for the PODs. After initial delivery, use rate of use information and travel time to establish re-supply routes and schedules for drivers. Coordinate with the Communications Unit Leader for additional communication needs between your unit and the drivers. Maintain communication with drivers as materiel is enroute to delivery points. Instruct drivers on obtaining signatures for product delivery at PODs, and returning signed documents to Materiel Unit Leader/Inventory Control Personnel. Maintain vehicle dispatch information (log, computer): Driver, vehicle description, time departed, route #, time returned. Make routine reports on product delivery status to the Materiel Unit Leader. Discuss problems or concerns with drivers. Re-design delivery routes, times as necessary. Coordinate with Security Unit Leader regarding protection of product in transit and traffic problems with routes to PODs. Maintain documentation of response costs, including equipment; overtime labor hours, and mileage. At a shift change, provide a detailed status report and all written materials to replacement staff. Provide summary reports on communication operations to RSS Branch Director for debriefing and final documentation.
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8.8 OP AREA RSS COMMUNICATIONS UNIT LEADER
Coordinate communication needs at the OA RSS; between drivers; the HHSA DOC; and the Op Area EOC as necessary. The OA RSS Communications Unit Leader reports to the RSS Branch Director. Coordinate with the Op Area EOC Communications Group.
Op Area RSS - COMMUNICATIONS UNIT LEADER CHECKLIST
Report and Sign-in at RSS Warehouse.
Assess communications needs for RSS operation, including: . RSS Branch Director; Security Unit Leader; from RSS to the Op Area EOC . Materiel Unit Leader from RSS to the Op Area EOC and the HHSA DOC . Transportation/Dispatch to Drivers . Shipping from RSS to PODs and other treatment sites
Develop communications plan.
Provide updates to the management team regarding communications issues and concerns at briefings.
Establish and maintain contact with Op Area EOC Logistics Section/ Communications Branch to request additional communications equipment and personnel resources and to provide status reports.
Provide instruction on new communication equipment users regarding operation of equipment, appropriate on-air protocol, and security of on-air communication.
Maintain inventory tracking of assigned equipment: documentation and signatures of recipients.
Develop listings of communication points and distribute to users as necessary (telephone numbers, radio frequencies, call signs, base stations, etc).
Maintain documentation of response costs, including equipment; overtime labor hours, and mileage.
At a shift change, provide a detailed status report and all written materials to replacement staff.
Provide summary reports on communication operations to RSS Branch Director for debriefing and final documentation.
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 34 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014
8.9 OP AREA RSS COMMUNICATIONS/ IS COORDINATOR
Report to the Communications Unit Leader. Coordinate IS communication needs at the OA RSS.
Op Area RSS – IS COORDINATOR CHECKLIST
Report and Sign-in at RSS Warehouse.
Report to the Communications Unit Leader.
Receive Communications Plan briefing.
Assess IS communications needs for RSS operation, including: . RSS Branch Director/ RSS to the Op Area EOC . RSS Materiel Unit/Inventory Control to the Op Area EOC and the HHSA DOC.
Provide and set-up ITS equipment (laptops and peripherals) to designated unit/staff.
Maintain inventory tracking of assigned ITS equipment.
Provide instruction on ITS equipment to users regarding operation of equipment, appropriate user protocol, and security of ITS communication systems.
Provide updates to the Communications Unit Leader regarding ITS communications issues and concerns.
At a shift change, provide a detailed status report and all written materials to Communication Unit Leader.
NAPA COUNTY HHSA PUBLIC HEALTH DIVISION page 35 ANNEX H - HHSA SNS/RSS FIELD OPERATIONS GUIDE Revised May 2014
8.10 OP AREA RSS SECURITY UNIT LEADER
Coordinate security requirements for the RSS Staging Area and materiel in transport. Provide traffic control for the staging area if required. The OA RSS Security Unit Leader reports to the OA RSS Branch Director. Coordinate with the Op Area EOC Law Enforcement Branch.
Op Area RSS - SECURITY UNIT LEADER CHECKLIST
Report and Sign-in at OA RSS Warehouse.
Assess security needs for staging area, including: . Site Access . Perimeter protection . Traffic control . Protection of staff, materiel and equipment . Controlled substance storage area . Materiel in movement
Develop security plan.
Provide security briefing to the security unit staff.
Obtain list of authorized personnel for RSS site, for use at access point for assigned staff.
Establish and maintain contact with Op Area EOC Law Enforcement Branch to request additional assistance and provide and receive security status reports.
Interact with Op Area EOC Law Enforcement Branch to request support from other Op Area EOC Branches. (Construction and Engineering, Human Resources).
Maintain documentation of response costs, including equipment, labor hours, and mileage.
At shift change, provide a detailed status report and all written materials to replacement staff.
Ensure security of staff and materiel during demobilization of the Staging Area.
Provide summary reports on security operations to RSS Branch Director for debriefing and final documentation.
Provide updates to the management team regarding security issues and concerns at briefings.
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8.11 SECURITY FOR OA RSS FACILITY
Reporting to the Security Unit Leader, security personnel provide security at the RSS Warehouse site.
Op Area RSS - SECURITY for OA RSS FACILITY CHECKLIST
Report and Sign-in at OA RSS Warehouse.
Report to the Security Unit Leader.
Participate in initial briefing. Receive information on the request of SNS, products ordered, expected timeframe, etc.
Receive Security Plan briefing.
Provide security at the RSS Warehouse area, as directed including: . Site Access . Perimeter protection . Traffic control . Protection of staff, materiel and equipment . Controlled substance storage area . Materiel in movement
If assigned to RSS access point, receive list of authorized RSS personnel from Security Unit Leader, and check all incoming person’s names and their ID; for anyone not on list, contact Security Unit Leader.
Provide updates to Security Unit Leader regarding security issues and concerns.
At a shift change, provide a detailed status report and all written materials to Security Unit Leader.
Ensure security of staff and materiel during demobilization of the RSS Warehouse Area.
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8.12 OP AREA RSS SAFETY OFFICER
Coordinate safety requirements for the RSS Warehouse area and materiel in transport. Provide safety training for the staging area if required. The OA RSS Safety Officer reports to the OA RSS Branch Director.
Op Area RSS – SAFETY OFFICER CHECKLIST
Report and Sign-in at OA RSS Warehouse.
Assess safety needs for RSS operations, including: . Personal Protective Equipment use . Environmental concerns . Protection of staff, materiel and equipment . Safety in any traffic and high-volume areas . Self-care monitoring
Develop safety plan.
Provide updates to the management team regarding safety issues and concerns at briefings.
At a shift change, provide a detailed status report and all written materials to replacement staff.
Ensure safety of staff and materiel during demobilization of the RSS Warehouse Area.
Provide summary reports on safety operations to RSS Branch Director for debriefing and final documentation.
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9. PUBLIC HEALTH EMERGENCY ASSESSMENT CRITICAL DATA WORKSHEETS
TIME IS OF THE ESSENCE:
DIRECTIONS:
PLANNING SECTION CHIEF or OTHER MEDICAL HEALTH OPERATIONAL AREA COORDINATOR DESIGNEE completes SITUATION REPORT. Instructions appear in SECTION A.
REGIONAL DISASTER MEDICAL HEALTH COORDINATOR/SPECIALIST (RDMHC/S) complete SECTION. B
AFTER COMPLETING IDENTIFIED SECTIONS, SUBMIT WORKSHEETS AS FOLLOWS:
1) MHOAC - TO - 2) RDMHC/S - TO - 3) CDPH & EMSA DUTY OFFICERS
Detailed instructions for both Worksheets are listed after Worksheet Section B.
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Section A:
SIT REP INSTRUCTIONS, TO BE COMPLETED BY PLANNING SECTION CHIEF OR OTHER MEDICAL HEALTH OPERATIONAL AREA COORDINATOR DESIGNEE
The SIT REP minimum data elements are: Report type (initial, update, final); Report status (advisory or alert); Report creation date/time; Incident information (operational area, mutual aid region, incident name/date/time/location, population affected, public health and medical incident level); Report creator (including contact information); Current condition of the public health and medical system; Prognosis (unchanged, improving, worsening); Descriptions of: o the current situation, o current priorities, o critical issues and actions taken, o activities, o emergency proclamations/declarations, o health advisories/orders; and Primary public health and medical contact person/information.
SNS-specific data elements include a summary of POD status, including number open or planned, as well as related comments.
Updated SIT REPs should be prepared once during each operational period; in response to significant changes in status, prognosis, or actions taken; and in response to requests for updates from the region or state, as communicated by the RDMHC program. All SIT REPS should be maintained as part of the incident historical document file.
An electronic version of the Medical and Health Situation Report is available for download from the California Health Alert Network (CAHAN) document library. In CAHAN, go to Document Library Documents 2 State and Local Health # CDPH EPO EOM Electronic SIT REP. The SIT REP can also be found online in the Napa County HHSA network at G:\!!Disaster DOC (Department Operations Center) folder, and on the Web at www.bepreparedcalifornia.ca.gov.
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Section Two, RDMHC/S Instructions:
10. SNS INVENTORY FORMS
10.1 SNS STATE TO LOCAL TRANSFER FORM
California Department of Public Health
Transfer Form
Strategic National and State Stockpile Program
The California Department of Public Health (CDPH) hereby transfers materiel from the Strategic National and State Stockpile into the custody and control of the receiving authority listed below. By signing this form, the receiving authority acknowledges receipt of the materiel listed on the accompanying manifest.
The receiving authority accepts full responsibility for the materiels entrusted into its possession and agrees to abide by the terms, conditions, and responsibilities, of all applicable agreements between the California Department of Health, and local authorities, as well as all applicable federal and state laws and regulations.
California Department of Public Health Authority SIGNATURE & DATE
(PRINT NAME & TITLE)
Authorized Receiving Authority SIGNATURE & DATE
(PRINT NAME & TITLE)
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(If Control Schedule II Substances are Transferred) SIGNATURE & DATE
Authorized Receiving Authority DEA Registrant
(PRINT NAME, TITLE, & DEA REGISTRATION NUMBER)
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10.2 RSS SNS INVENTORY FORMS
10.2.1 SNS RSS TRACKING FORMS’ FLOW CHARTS
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10.2.3 DISTRIBUTION PICK LIST FORM
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11. MORE ABOUT THE STRATEGIC NATIONAL STOCKPILE
SNS Mission
The mission of CDC's Strategic National and State Stockpile (SNS) Program is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of nerve agents, biological pathogens, and chemical agents. The SNS Program stands ready for immediate deployment to any U.S. location in the event of a terrorist attack using a biological toxin or chemical agent directed against a civilian population.
Phases of Deployment
Following the federal decision to deploy, the SNS will typically arrive by air or ground in two phases. The first phase shipment is called a 12-hour Push Package. “12” because it will arrive in 12-hours or less, “push” because a state need only ask for help—not for specific items, and “package” because the Program will ship a complete package of medical materiel—to include nearly everything a state will need to respond to a broad range of threats.
The second phase consists of inventory supplies known as Vendor Managed Inventory, or VMI packages. VMI packages can be tailored to provide pharmaceuticals, vaccines, medical supplies and/or medical products specific to the suspected or confirmed agent or combination of
NAPA COUNTY PUBLIC HEALTH DIVISION page 45 ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 agents. The 12 Push Packages together represent 20% of SNS resources, while the other 80% is contained in the VMI.
Features of a Push Package
Each Push Package weighs about 50 tons and arrives in approximately 130 aircraft cargo containers that are designed so that one person can easily roll them around. Container dimensions are 43” wide by 60” long. Tall containers are 80” high, and short containers are 64.5 inches high. Eight 53’ climate controlled tractor-trailers are required to transport one Push Package. Each Push Package contains enough antibiotics to treat 208,000 people for 10 days. If more are needed, an additional Push Package may be sent and/or they will be provided by the VMI. There are photographs of a Push Package on the following page.
A list of the contents of each container is found inside an envelope attached to the outside. The CDC staff arrives with an electronic inventory of the Push Package, which can be uploaded into a spreadsheet program to assist with local inventory tracking.
The antibiotics are 48% Ciprofloxacin, 48% Doxycycline, and 4% pediatric (chewable) Amoxicillin. There are also limited quantities of the nerve agent antidotes, Atropine and Pralidoxime Chloride (Mark 1 autoinjectors). Vaccines and other Items requiring refrigeration arrive in Vaxipacs, which are powered by batteries that will hold their charge for 9 days. The batteries can be recharged by AC or DC current or solar energy.
A CDC team of five or six technical advisors will also deploy at the same time as the first shipment. Known as a Technical Advisory Response Unit (TARU), this team is comprised of pharmacists, emergency responders, and logistics experts that will advise local authorities on receiving, distributing, dispensing, replenishing, and recovering NPS materiel.
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12. INVESTIGATIONAL NEW DRUG/EMERGENCY USE AUTHORIZATION
Several of the vaccines and pharmaceuticals for which mass prophylaxis operations may be activated may be administered under an Investigational New Drug (IND) protocol or Emergency Use Authorization (EUA) procedures. The purpose of this section is to describe the effect upon dispensing operations of these two similar alternative procedures.
12.1 EMERGENCY USE AUTHORIZATION (EUA)
12.1.1 BACKGROUND
Project BioShield Act of 2004 amended section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3). Section 564 permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product upon: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent; or (2) a determination by the Secretary of a public health emergency that affects, or has a significant potential to affect, national security and that involves a specified biological, chemical, radiological, or nuclear agent or a specified disease or condition that may be attributable to such agent.
Under section 564, the Food and Drug Administration (FDA) Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat, or prevent serious or life- threatening diseases or conditions caused by such agents, when there are no adequate, approved, and available alternatives.
The FDA expects that requests for consideration for an EUA would be submitted by government agencies (e.g., the Department of Health and Human Services or the Department of Defense (DoD) or private entities.
Additionally, the Secretary of Health and Human Services (the Secretary) will establish a permanent Emergency Use Authorization Working Group (EUA WG), headed by the Assistant Secretary of Public Health Emergency Preparedness (ASPHEP), with representatives from FDA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Department of Defense (DoD), the Department of Homeland Security (DHS), the Department of Veterans Affairs and, as appropriate, participants from other Federal agencies, to
NAPA COUNTY PUBLIC HEALTH DIVISION page 48 ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 identify and provide expert consultation on potential EUA candidates prior to and during declared emergencies. 1
FDA recommends that a request for consideration for an EUA include a discussion of the candidate product's known and potential risks and benefits, which includes a synthesis of data and information, including:
a. Measures taken to mitigate risk or optimize benefit;
b. Limitations, uncertainty, and data gaps; and
c. A description of circumstances, if any, under which the product should not be used (e.g., contraindications).
12.1.2 LOCAL PUBLIC HEALTH EUA IMPLEMENTATION
The Napa County Public Health Officer is responsible to ensure that the professionals administering the product and individuals to whom the product is administered are informed:
That the Secretary has authorized the emergency use of the product;
Of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and
Of the alternatives to the product that are available, and of their benefits and risks.
Individuals to whom the product is administered must be additionally informed of:
The option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product.
The Napa County Public Health Officer is also responsible, locally for:
Monitoring and reporting of adverse events associated with the emergency use of the product.
To complete these requirements the NAPA HHSA PHD utilizes the information sheets provided with the SNS (1) to provide training to mass dispensing site clinical workers and (2) to screen for contra-indications, distribute the information statements; explain and gain Informed Consent. Adverse events monitoring is completed through use of the Vaccine Adverse Events Reporting
1 http://www.fda.gov/oc/bioterrorism/emergency_use.html#introduction Accessed August 15, 2007
NAPA COUNTY PUBLIC HEALTH DIVISION page 49 ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 System (VAERS) , or other data reporting system as identified for specific use by the California Department of Public Health (CDPH).
12.1.3 INVESTIGATIONAL NEW DRUG (IND) PROCEDURES
The Smallpox vaccine is one example of a SNS product which may be administered as an IND. The IND forms required by the FDA are included with the SNS. Although changes may occur to the following documents prior to SNS deployment they are provided here for example.
Screening for contraindications, explaining and gaining informed consent, and monitoring for adverse events are performed at the dispensing site.
The following forms and patient educational materials are extracted from the CDC Smallpox Planning Guide, Annex 3, “Guidelines for Large Scale Smallpox Vaccination Clinics”, 9/16/2002 Examples of Supporting IND Forms for Smallpox Vaccine Clinics*
“* IND forms are subject to change, they are included for planning purposes only. The most current IND forms will be distributed with vaccine shipments or available through the state- based co-investigator and should be utilized for all actual IND program administration within vaccination clinics.”
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Investigational Smallpox Vaccine
Screening and Consent Signature Form
Date:
Patient Identifying Number:
(Please check only one: SSN Passport # Driver’s license # and Issuing State:____ Other , List:______None available )
Participant Information:
Print Name: Date of Birth: Sex: M F
Current Address:
City State Zip code Telephone Number
Contact History:
Have you been told that you may have been a contact to someone with smallpox? Yes No
Have you been in contact with someone who had a bad rash in the past 3 weeks? Yes No
Screening:
Do the following apply to you or your child?
Yes No Maybe
Immune system problems such as HIV/AIDS, cancer, leukemia, lymphoma, organ transplant, gammmaglobulinemia
Autoimmune system problem like lupus that weakens your immune system
Currently taking medicines like oral steroids (such as prednisone), chemotherapy agents/radiation, or organ transplant medications.
Eczema, atopic dermatitis, or a history of eczema or atopic dermatitis
Other skin conditions such as burns, impetigo, contact dermatitis, or zoster.
Currently pregnant
Allergy to antibiotics polymixin B, streptomycin, chlortetracycline, neomycin
Age less than 1 year old
Have additional questions about any health conditions you might have and whether you should be vaccinated
Are you less than 18 years of age and your parent or guardian is not with you?
Do you have any questions you would like to have answered before you decide on vaccination?
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This adult is incapacitated and this screening/consent signature form is being completed by the parent or guardian [checked box for this question alone does not require additional screening counseling]
Participant Informed Consent Signature for Vaccination:
I HAVE:
. Viewed the vaccine informational video or read the video script in the packet, or talked with a translator.
. Received the information packet (which includes information on why this vaccine is being offered, why it is investigational, voluntary participation, benefits, risks, side effects, risks to contacts, precautions for vaccination and adverse events, Vaccinia Immune Globulin, cidofovir, care of my vaccination site, confidentiality, costs, what to do in case of injury, my right to refuse, alternative treatments, and contact information for problems or questions.)
. Completed the medical screening form
. Received counseling and additional information if I was identified as a contact or fell into any of the groups listed on the front of this form
. Had the opportunity to have my questions answered
. I have been informed of why smallpox vaccine is being made available, the risks and benefits associated with vaccination and based on the information provided to me, I have decided to receive or have my child receive smallpox vaccination today.
Participant Signature/ Parent or Guardian:
FOR VACCINATOR USE ONLY
Vaccine clinic ID: Vaccinator ID (name or ID number):
Vaccine Name: Dryvax Aventis ACAM1000 ACAM2000 Lot #:
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SMALLPOX VACCINE INVESTIGATION OF NEW DRUG (IND) RECORD OF IMMUNIZATION
Bring this card with you if you present for revaccination or for evaluation of a vaccine related illness.
Name: ______
Patient Identifying Number (use same ID# as Medical Screening Form):
Please identify that this number is:
SSN
Passport # and Issuing Country_____
Drivers license # and Issuing State: _____
Other: List______
None available
Address: ______
(City) (State) (Zip code)
Telephone: (______)______
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BELOW TO BE FILLED OUT BY VACCINE ADMINISTRATORS
Date (mm/dd/yy) Vaccine Type Vaccine LOT # Vaccination Site Clinic Name Person administering vaccine (check box) (check box)
Dryvax
Aventis Right arm
ACAM1000 Left arm
ACAM2000 Other
Dryvax
Aventis Right arm
ACAM1000 Left arm
ACAM2000 Other
Dryvax
Aventis Right arm
ACAM1000 Left arm
ACAM2000 Other
Dryvax
Aventis Right arm
ACAM1000 Left arm
ACAM2000 Other
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Temporary Proof of Vaccination and Site Check Reminder Sheet (To be Completed by Clinic Staff and Kept by the Vaccine)
IMPORTANT: KEEP THIS FORM. BRING IT WITH YOU TO YOUR VACCINATION SITE CHECK. Please bring this sheet with you to your vaccination site check appointment and keep it for the next 4 weeks. This sheet contains the phone number you should call if you think you are having a bad reaction to the vaccine. This sheet is also your proof of vaccination until you come back to the clinic for your vaccination site check. On that date, you will get your permanent immunization card. TEMPORARY PROOF OF SMALLPOX VACCINATION: Name: ______Date vaccinated: / / PVN: ______Clinic: ______Clinic Telephone No.: (_____)______-______Arm Vaccinated: Left Right APPOINTMENT FOR REQUIRED VACCINATION SITE CHECK: You will need to get your vaccination site checked on the date below to make sure the vaccination worked. Date of Appointment: / / ____ Time: ______Clinic Name: ______Street Address______City______State______Zip ______Clinic Telephone No.: (______)______- ______
IF YOU THINK YOU ARE HAVING A BAD REACTION TO THE VACCINE: Call: ______, call your health care provider, or visit an emergency room. IMPORTANT: DO NOT DISCARD THIS FORM. BRING IT WITH YOU WHEN YOU RETURN FOR YOUR VACCINATION SITE CHECK. For more information, visit www.cdc.gov/smallpox, or call the CDC public response hotline at (888) 246-2675 (English), (888) 246-2857 (Español), or (866) 874-2646 (TTY)
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13. REFERENCE MATERIALS - Project BioShield Act of 2004, SEC. 564
Project BioShield Act of 2004, SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES
Selected sections2:
(a) IN GENERAL-
(1) EMERGENCY USES- Notwithstanding sections 505, 510(k), and 515 of this Act and section 351 of the Public Health Service Act, and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an emergency use').
(2) APPROVAL STATUS OF PRODUCT- An authorization under paragraph (1) may authorize an emergency use of a product that--
(A) is not approved, licensed, or cleared for commercial distribution under a provision of law referred to in such paragraph (referred to in this section as an unapproved product'); or
(B) is approved, licensed, or cleared under such a provision, but which use is not under such provision an approved, licensed, or cleared use of the product (referred to in this section as an ‘unapproved use of an approved product').
(4) DEFINITIONS- For purposes of this section:
(A) The term ‘biological product' has the meaning given such term in section 351 of the Public Health Service Act.
(B) The term ‘emergency use' has the meaning indicated for such term in paragraph (1).
(C) The term ‘product' means a drug, device, or biological product.
(D) The term ‘unapproved product' has the meaning indicated for such term in paragraph (2)(A).
2 http://www.govtrack.us/congress/bill.xpd?bill=s108-15 Accessed August 15, 2007
MAY 2014 NAPA COUNTY HHSA PUBLIC HEALTH DIVISION 56 ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 (E) The term ‘unapproved use of an approved product' has the meaning indicated for such term in paragraph (2)(B).
(b) DECLARATION OF EMERGENCY-
(1) IN GENERAL- The Secretary may declare an emergency justifying the authorization under this subsection for a product on the basis of--
(A) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents;
(B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or
(C) a determination by the Secretary of a public health emergency under section 319 of the Public Health Service Act that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.
(c) CRITERIA FOR ISSUANCE OF AUTHORIZATION- The Secretary may issue an authorization under this section with respect to the emergency use of a product only if, after consultation with the Director of the National Institutes of Health and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the circumstances of the emergency involved), the Secretary concludes--
(1) that an agent specified in a declaration under subsection (b) can cause a serious or life-threatening disease or condition;
(2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that--
(A) The product may be effective in diagnosing, treating, or preventing--
(i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a product authorized under this section, approved or cleared under this Act, or licensed under section 351 of the Public Health Service Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and
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ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product;
(3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; and
(4) that such other criteria as the Secretary may by regulation prescribe are satisfied.
(d) SCOPE OF AUTHORIZATION- An authorization of a product under this section shall state- -
(1) each disease or condition that the product may be used to diagnose, prevent, or treat within the scope of the authorization;
(2) the Secretary's conclusions, made under subsection (c)(2)(B), that the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product; and
(3) the Secretary's conclusions, made under subsection (c), concerning the safety and potential effectiveness of the product in diagnosing, preventing, or treating such diseases or conditions, including an assessment of the available scientific evidence.
(e) CONDITIONS OF AUTHORIZATION-
(1) UNAPPROVED PRODUCT-
(A) REQUIRED CONDITIONS- With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the circumstances of the emergency, shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:
(i) Appropriate conditions designed to ensure that health care professionals administering the product are informed--
(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and
(III) of the alternatives to the product that are available, and of their benefits and risks.
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ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 (ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed--
(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
(iii) Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the product.
(iv) For manufacturers of the product, appropriate conditions concerning recordkeeping and reporting, including records access by the Secretary, with respect to the emergency use of the product.
(B) AUTHORITY FOR ADDITIONAL CONDITIONS- With respect to the emergency use of an unapproved product, the Secretary may, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:
(i) Appropriate conditions on which entities may distribute the product with respect to the emergency use of the product (including limitation to distribution by government entities), and on how distribution is to be performed.
(ii) Appropriate conditions on who may administer the product with respect to the emergency use of the product, and on the categories of individuals to whom, and the circumstances under which, the product may be administered with respect to such use.
(iii) Appropriate conditions with respect to the collection and analysis of information, during the period when the authorization is in effect, concerning the safety and effectiveness of the product with respect to the emergency use of such product.
(iv) For persons other than manufacturers of the product, appropriate conditions concerning recordkeeping and reporting, including records
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ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 access by the Secretary, with respect to the emergency use of the product.
(2) UNAPPROVED USE- With respect to the emergency use of a product that is an unapproved use of an approved product:
(A) For a manufacturer of the product who carries out any activity for which the authorization is issued, the Secretary shall, to the extent practicable given the circumstances of the emergency, establish conditions described in clauses (i) and (ii) of paragraph (1)(A), and may establish conditions described in clauses (iii) and (iv) of such paragraph.
(B)(i) If the authorization under this section regarding the emergency use authorizes a change in the labeling of the product, but the manufacturer of the product chooses not to make such change, such authorization may not authorize distributors of the product or any other person to alter or obscure the labeling provided by the manufacturer.
(ii) In the circumstances described in clause (i), for a person who does not manufacture the product and who chooses to act under this clause, an authorization under this section regarding the emergency use shall, to the extent practicable given the circumstances of the emergency, authorize such person to provide appropriate information with respect to such product in addition to the labeling provided by the manufacturer, subject to compliance with clause (i). While the authorization under this section is effective, such additional information shall not be considered labeling for purposes of section 502.
(C) The Secretary may establish with respect to the distribution and administration of the product for the unapproved use conditions no more restrictive than those established by the Secretary with respect to the distribution and administration of the product for the approved use.
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14. REFERENCES
After Action Report, Dispensing Demonstration Conducted January 24th 2002, Washington State National Pharmaceutical Stockpile Planning Committee.
Dallas County Health and Human Services National Pharmaceutical Stockpile and Pharmaceutical Distribution Plan, (Version 1.0, March 2003).
Lessons Learned from Tucson MMRS Bio-Terrorism, NPS, Mass Dispensing Site, Conference and Exercise by Les Caid, Tucson Fire Department (April 2003).
Medication for the Masses: Pharmacy’s Role in Times of Crisis by Theodore G. Tong and David Von Behren (April 2003).
National Pharmaceutical Stockpile Planning Software User Manual, CDC, (Version 2).
National Pharmaceutical Stockpile Preparedness Course, CDC (Books 1 & 2, August 2002).
Receiving, Distributing, and Dispensing the National Pharmaceutical Stockpile,
A Guide for Planners, CDC (Version 9, April 2002).
Sample Plan for Distribution of the National Pharmaceutical Stockpile, CDC (Draft).
Sonoma/Operational Area County Management Plan (Draft), July 2003
Sonoma County Bioterrorism Response Plan (Draft 3).
Sonoma County / Operational Area Emergency Operations Plan (November 2000).
State of California Mass Prophylaxis Planning Guide (Draft, Version IV, December 2002). From the California Department of Public Health and the Emergency Medical Services Authority.
Santa Clara County / Volume 2 – Annex D – Plan (August 2005)
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ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 15. GLOSSARY
For SNS planning purposes the term is used to represent the delivery of SNS materiel from the State RSS Site to the Operational Area RSS site (staging area) and/or local jurisdiction dispensing Distribution site(s) such as (hospitals, etc.) and/or local mass medication dispensing center(s).
For SNS planning purposes the term is used to describe the process that takes place at the selected sites where repackaged prophylaxis Dispensing medications are provided to the affected population.
Department of Transportation/Regional Transportation Representative. DOT/RETREP
Military Support to Civil Authority MSCA
Five critical questions to address previous to the state requesting a Push Package. CDC/SNS will ask: 1) Morbidity 2) Mortality 3) Lab requesting criteria Results 4) Field Indicators 5) Other states (CA: counties) affected.
Strategic National Stockpile: Consists of two parts, the “12-Hour Push Package” and Vendor Managed Inventory (VMI), plus other items for disaster response, for example, blankets. The SNS SNS Program, developed and administered by National Centers for Disease Control and Prevention (CDC) for distribution to a requesting State in the event of a biological or chemical terrorism event. transfer Legal CDC document that, when signed by CDC and the State authorized official, transfers the custody of the SNS materiel from the
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ANNEX H - APPENDIX 3: HHSA STRATEGIC NATIONAL STOCKPILE PLAN Revised May 2014 CDC to the State. custody form
Official document used by CDC and the State that, when signed by CDC and the State authorized official, acknowledges and accepts an MEMORANDUM agreement for materiel maintenance and financial obligation of the OF UNDERSTANDING SNS assets.
DEA TRANSFER OF Official federal document used by licensed and registered Public Health Nurses and/or physicians to transfer from one party to CONTROLLED another party a pharmaceutical resource listed on the “controlled substances list”. SUBSTANCE FORM
Source: Concept of Operations for the Strategic National Stockpile.
California Office of Emergency Services, April 2003
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